Medical Device Regulatory Consulting

Helping you on your regulatory journey with expert Medical Device Regulatory Consultancy.

Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy
Patient Guard provide professional Regulatory Affairs and Quality Assurance services through Medical Device and In-Vitro Diagnostics consultancy.

Trusted by leading organisations across the UK, US & Europe

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Our core services

We provide a full range of industry-leading Medical Device Regulatory and Quality Services for a wide variety of medical device organisations across the UK, USA and Europe.

Quality Assurance audits
Auditing
Services
Internal auditing for medical devices plays a pivotal role in ensuring regulatory compliance, quality assurance, and patient safety within the healthcare industry.
Medical device testing and biological evaluation
Biological
Evaluation
Medical device biological evaluation is a critical aspect of ensuring their safety and efficacy for use in healthcare settings.
cosmetics
Cosmetic
Responsible Person
Cosmetics regulations are comprehensive frameworks designed to ensure the safety, quality, and efficacy of cosmetic products while safeguarding consumer health.
medical device consultancy
Medical Device
Consultancy
We are dedicated to helping manufacturers navigate the complexities of regulatory compliance and achieve market success.
medical device and IVD technical files - Quality Management System - Internal Auditing services
CE Mark & UKCA Mark
Technical Files

We provide support in updating your technical including modifications or design updates to your device, revising and enhancing your risk management file, and ensuring your files are compliant.

clinical evaluation and Post Market Clinical Follow-up (PMCF). Investigational Device Exemption.
Clinical
Evaluation

Our clinical evaluation services are designed to support manufacturers in navigating the complex regulatory landscape, ensuring that their medical devices and IVDs meet the highest standards.

ISO 13485 Quality Management System
Quality Management
System
Medical device quality management is a comprehensive framework designed to ensure that medical devices consistently meet the regulatory requirements as well as fulfil the needs and expectations of patients and healthcare providers.
FDA medical device and IVD services
FDA
Services
When it comes to launching your medical device in the US market, navigating the intricate landscape of FDA regulations is crucial.
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Our Approach

We can help you at any stage of the Medical Device and IVD Regulatory roadmap

patient guard road map
Concept
Concept

Do you have a medical device or IVD idea? Are you a medical device start up? If so the prospect of medical device and IVD regulations can be daunting, especially if you have not done it before.

Design
Design

Once you have come up with the medical device or IVD concept, its time to start design and development.

manufacturing
Manufacturing

Once the design has been finalised its time to transfer to manufacturing. This can be challenging and may require design changes to ensure that the device can be scaled.

product launch
Launch

Before you launch your medical device or IVD, it is important to ensure that you have met all of your regulatory obligations before placing product on the market.

post market surveillance
Post Market

Monitoring a medical device and IVD is important once it has been launched, to ensure that any unforeseen risks are captured and mitigated.

medical device retirement or obsolescence
Obsolescence

Need to understand your obligations?

Helping You on Your Regulatory Journey

Contact us for a free consultation about your Medical Device Regulatory & Quality Assurance needs.

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Why Organisations Choose Patient Guard

Expertise &
Experience

With over 20+ years of experience, we have not only amassed valuable insights but have also successfully guided lots of clients through the regulatory maze.

Tailored
Solutions

Recognising the unique nature of every Medical Device, our approach is highly customised. We meticulously tailor our services to meet the specific needs of your products and organisation, ensuring a personalised and effective regulatory strategy.

End-to-End
Support

We offer comprehensive support that spans the entire product lifecycle. From initial consultations, to ongoing compliance management and even training courses, we are your dedicated partners.

Timely
& Efficient

We recognise the importance of time in the competitive landscape. Patient Guard prides itself on delivering timely and efficient services.

Committed
Partners

In choosing Patient Guard as your Medical Device Regulatory & Quality Assurance Partner, you’re not merely selecting a service provider; you’re opting for a dedicated partner committed to your success.

Our Friendly Team are here to help.

For a free consultation about your Medical Device Regulatory & Quality Assurance needs.

patient guard

Patient Guard are an excellent source of medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with technical files all the way through to using their ISO templates to implement our ISO 13485 system.”

Richard Crow

patient guard

Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.”

Tracey Slater, Cormed

Latest news from Patient Guard

Patient Guards November 2024 News Letter

November 2024 News Letter

Welcome to our November 2024 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued.

Read More »
image of a blue circle with EU written in the middle and yellow stars all around the circle. This image represents the European Union (EU). The imaged is used by Patient Guard limited to highlight their EU Authorised Representative (EUAR) services and also to highlight areas on their website that cover EU regulatory requirements or news.

EU Authorised Representative

The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.

Since the MDR and IVDR

Read More »
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Do you need support with Medical Device or IVD compliance?

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